Decision Diagnostics Grapples With FDA Emergency Use Authorization Process

September 10, 2020
Grant M. Gallagher
Grant M. Gallagher

Decision Diagnostics Corp. has submitted 2 applications with the FDA for a COVID-19 testing technology that the firm claims can identify the virus in about 10 seconds.

Keith Berman is CEO of Decision Diagnostics Corp. a California based manufacturer of testing technologies that has submitted 2 applications with the US Food and Drug Administration (FDA) for a COVID-19 diagnostic technology that the firm claims can identify the virus in about 10 seconds.

The company has been in discussions with the FDA on final testing protocols since mid-April.

Contagion: What is meant by the term “rapid test?"

Berman: Many have used the term “rapid” but there’s yet to be a truly rapid Covid-19 test that doesn’t involved caveats. Such caveats are the requirement to have a health care professional involved in administering the test or needing advanced and expensive machines to produce testing results. Our GenViro! Swift kits perform tests in a rapid fashion, 10.5 seconds and while the first FDA approval will be for professional administration of the kit, the same kit will eventually, FDA permitting, be available for at-home individual use.

A truly rapid test such as the Decision Diagnostics under 10.5 second saliva based test are indeed rapid because they provide almost instant results and the testing doesn’t require a professional to conduct it or advanced and expensive technology to produce a result. Ours is a technology and methodology based upon diabetes glucose testing model using a test strip and meter or reader. Although our GenViro! test strip is made to identify the Covid-19 virus, diabetic users will immediately recognize the kit, as this type of technology has been in use by millions of diabetics around the globe multiple times daily for decades. The tests are currently made for professional administration but the goal is also FDA authorization for self-administered testing, meaning they are also built for at-home and more individually oriented testing than any of the point of care testing approved so far. Our Korean testing partner tells us these tests are accurate and we know based on our two decades of experience in the diabetes testing realm that we can make them affordable and scalable as well.

Contagion: What are the benefits of a rapid test, both for patients and the overall outbreak response strategy?

Berman: A rapid test such as ours whose methodology is widely accepted and used daily around the world will help identify those testing positive immediately as well as allow those testing to do so multiple times per day. As a matter of fact, should someone using our testing method get a reading that they don’t believe, they can immediately take another test right on the spot to validate the first test. With such immediate results people will know to quarantine right away should their test be positive and therefore reduce their ability to spread the virus even if they are asymptomatic. Such ability would allow schools and offices to open, give people the opportunity to gather more safely knowing they have tested positive either because they’ve tested themselves or because someone has conducted the test for them at a specific location like a church, theater, event, etc.

Contagion: What are some of the regulatory barriers to accessing these benefits?

Berman: Unfortunately, there have been countless regulatory barriers to obtaining the FDA emergency authorization we are seeking to be able to make the test available in the US. While we are already working with a distributor internationally and while others from overseas are showing great interest, the US is lagging. The FDA has changed the guidance for antigen tests at least 4 times as far as I can recall and we had our original EU application for our blood testing methodology submitted back in April. That has not gone anywhere. Now we have a saliva testing product and are working to secure a US based testing partner because the FDA will not accept the results and testing we have done in Korea. We are working to make this happen in the US as quickly as we can but that’s still a work in process and we expect to be available internationally before we are available in the US.

Contagion: What further do infectious disease experts need to know about what’s going on with the pipeline side of testing, from your perspective?

Berman: This is an interesting question. It appears that after some fits and starts a consensus is building to pressure the FDA to authorize slightly less accurate (but still very accurate) point of care methods that provide a test result in 5 minutes or less. This type of test will alleviate the standing in line for hours to take a test, and then wait days for a result to be reported. We are ahead of this pack because our kit completes a test in less than a minute, including opening the kit, collecting the saliva and then performing the assay and presenting a result. Many of us look forward to this day, and we believe announcement of new FDA “screening” guidelines will take place at just about the same time, mid-October, as we hear about several successful Covid-19 vaccine trials.

Company Bio:

Decision Diagnostics Corp. is the leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters. DECN's products are designed to operate efficiently and less expensively on certain glucose meters already in use by almost 7.5 million diabetics worldwide. With newly inspired technology diabetic test strips already in the final stages of development, DECN products compete on a worldwide scale with legacy manufacturers currently selling to 71+ percent of a $15+ billion at-home testing market. The company's new GenViro!product designed to test for Covid-19, is not yet available in the United States or Puerto Rico, but Emergency (EUA) Waivers are in process with the U.S. FDA.